Study of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Locally Advanced and Metastatic Non-Small Cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates Navtemadlin (KRT-232) in combination with Pembrolizumab as a maintenance therapy in patients with locally advanced and metastatic non small cell lung cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kartos Therapeutics, Inc.
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• ECOG 0-1

• Histologically or cytologically confirmed diagnosis of NSCLC documented as TP53WT

• Locally advanced or metastatic disease; must have completed up to 4 cycles of platinum-based chemo plus CPI and achieved a CR or PR per RECIST V1.1

• Adequate hematologic, hepatic and renal function (within 14 days)

Exclusion Criteria:

• Symptomatic or uncontrolled central nervous system (CNS) metastases

• Prior treatment with a MDM2 inhibitor

• Grade 2 or higher QTc prolongation (>480 msec per NCI-CTCAE criteria version 5.0)

• History of bleeding diathesis; major hemorrhage or intracranial hemorrhage within 24 weeks

• History of major organ transplant

• Active pneumonitis or known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis

• Prior radiotherapy, cytoreductive therapy, cytokine therapy or any investigational therapy within 28 days

• Medical condition, serious intercurrent illness, psychiatric condition or other circumstance that, in the Investigator's judgment could jeopardize the subject's safety, or that could interfere with study objectives